Text Size

Outcome Measures for Pediatric Wheelchairs in Low-resource Settings (Wheels)

This study is currently recruiting participants.
Verified February 2012 by Bethany Relief and Rehabilitation International Inc.
Sponsor:
Collaborators:
LeTourneau University
Queen's University
Information provided by (Responsible Party):
Bethany Relief and Rehabilitation International Inc.
ClinicalTrials.gov Identifier:
NCT01530425
First received: June 21, 2011
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

Two wheelchair types available for children in Kenya are compared for energy costs, utility, and complications. This study will arrive at a protocol for comparing wheelchairs in low-income settings, and in the process, provide wheelchair makers and providers with specific feedback. It also serves as a means to increase the skills of local health professionals working with the children in this study, while providing them with appropriate wheelchairs to use.


Condition
Shoulder Impingement
Pressure Ulcer

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Development of a Suite of Outcomes Measures Suitable for Use in Low-resource Settings to Compare Pediatric Wheelchairs Within the Framework of the International Classification of Function, Disability and Health

Resource links provided by NLM:

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Further study details as provided by Bethany Relief and Rehabilitation International Inc.:

Primary Outcome Measures:
  • physiologic costs (FEW) [ Time Frame: within 1 year of wheelchair acquisition for each phase ] [ Designated as safety issue: Yes ]
    energy costs will be measured, feedback will be obtained from children (VAS)


Secondary Outcome Measures:
  • medical complications [ Time Frame: within 24 months after wheelchair distribution for each phase ] [ Designated as safety issue: Yes ]
    direct assessment by physician for Musculoskeletal and Skin complications

  • participation [ Time Frame: within 24 months after wheelchair distribution for each phase ] [ Designated as safety issue: No ]
    using decriptive data to describe effect of wheelchair use on participation in school and play


Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Phase 1 comparison
Regency Wheelchairs vs. APDK 12-inch wide wheelchairs
Healthy volunteers
Children pairs in US, 1 high school student pushing 1 elementary student, to test wheelchairs used in study

  Eligibility

Ages Eligible for Study:   6 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children with disabilities in a primary school in Kenya who would benefit from available study wheelchairs, and who can provide feedback. Assent provided with parental consent.

Criteria

Inclusion Criteria:

  • Children who would benefit from available study wheelchairs who are able to provide feedback

Exclusion Criteria:

  • Children who are not able to provide feedback on the study wheelchairs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530425

Contacts
Contact: Joy Wee, MD 613-544-2143 weej@queensu.ca

Locations
Kenya
Kenyan Primary School Recruiting
Thika, Kenya
Sponsors and Collaborators
Bethany Relief and Rehabilitation International Inc.
LeTourneau University
Queen's University
Investigators
Principal Investigator: Karen Rispin LeTourneau University
  More Information

No publications provided

Responsible Party: Bethany Relief and Rehabilitation International Inc.
ClinicalTrials.gov Identifier: NCT01530425     History of Changes
Other Study ID Numbers: BKK-WRWC
Study First Received: June 21, 2011
Last Updated: February 9, 2012
Health Authority: Kenya: Ethical Review Committee

Keywords provided by Bethany Relief and Rehabilitation International Inc.:
pediatric wheelchairs
low-income
comparisons

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Shoulder Impingement Syndrome
Skin Ulcer
 Skin Diseases
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013